The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date ...

The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...

Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed promising response rates in patients with advanced, unresectable, or metastatic pheochromocytoma and ...

The FDA has accepted the application for belzutifan for advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

Rahway: Merck, known as MSD outside of the United States and Canada, has announced the U.S. Food and Drug Administration (FDA ...

“Pheochromocytoma and paraganglioma are rare tumors that form in and around the adrenal glands, and currently, there are no approved therapies available in the US for patients with this rare ...

The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 26, 2025. “Pheochromocytoma and paraganglioma are rare tumors that form in and around the adrenal glands, and ...

The FDA accepts and grants priority review to Merck's sNDA for Welireg to treat advanced pheochromocytoma and paraganglioma.

The US Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) for ...

Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the ...